BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2 GALLON SHARPS CONTAINER

    MDR report key: 1833601 · Received September 7, 2010

    Report

    Report Number
    1030451-2010-00004
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDEGEN
    Product Code
    MMK
    PMA / PMN Number
    K961878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT PASSED PENETRATION TESTING (ASTM REQUIREMENT IS 2.8 MIN) ON THE LOT SAMPLE (4.7 TO 5.3) AND THE RETURNED COMPLAINT SAMPLE (5.0). THE NEEDLE PENETRATED THE BOTTOM OF THE SHARPS CONTAINER. SINCE THE CONTAINER PASSED THE PENETRATION TEST, THIS WOULD INDICATE THAT THE CONTENTS MIGHT HAVE BEEN COMPRESSED TOO TIGHTLY INTO THE CONTAINER, FORCING A NEEDLE THROUGH THE WALL. SINCE THE SAMPLE WAS RECEIVED WITHOUT THE CONTENTS, THIS CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    A NURSE WAS MOVING THE SHARPS CONTAINER AND WAS STUCK IN THE HAND/FINGER BY A SYRINGE NEEDLE THAT HAD PENETRATED THE LOWER WALL OF THE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 GALLON SHARPS CONTAINER SHARPS CONTAINER MMK MEDEGEN 101-8704 1808-401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention